An interventional study of Atusin CAP and Placebo in Acute Bronchitis, sponsored by Neopharm Bulgaria Ltd.. Completed at 1 site in Bulgaria. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Neopharm Bulgaria Ltd. · Not applicable, Interventional, and Treatment
The study aims to evaluate the effectiveness and safety of Atusin® CAP in reducing the severity of acute bronchitis.
A prospective, multicenter, double-blind, placebo-controlled, randomized, parallel study will be conducted to evaluate the effect of Atusin® CAP on the rapid relief of irritating cough in adults with acute bronchitis treated in actual clinical practices in primary healthcare, where patients seek help as a result of serious complaints.
The combination of the three extracts: a mix of essential oils, bromelain and green Brazilian propolis may represent a breakthrough in symptomatic treatment by blocking the triggering mechanisms of cough due to acute bronchitis.
156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.
This study's enrollment of 310 is above the median of 185 across 105 interventional studies indexed under Bronchitis.
Browse Bronchitis studies →Neopharm Bulgaria Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male and female ambulatory subjects
Clinical diagnosis of "Acute bronchitis" meeting the following criteria:
Exclusion Criteria:
History of or current confounding respiratory disease (for example, , allergic rhinitis, chronic sinusitis or chronic bronchitis - including acute exacerbations, emphysema, bronchiectasias, asthma, cystic fibrosis, tuberculosis, lung cancer, etc.); lung radiogram revealing pulmonary inflammatory lesions; suspected pneumonia - imaging diagnostics is used mainly to rule out pneumonia.
ACCP 2006 Guidelines point out that an imaging assessment is not indicated in patients with symptoms of acute bronchitis, who have normal vital signs and normal pulmonary evaluation.33 Absence of the following findings reduces the likelihood of pneumonia sufficiently to eliminate the need of chest radiogram or hospital admission:
Active concurrent disease which may interfere with subject's ability to participate in the study, in the judgement of Investigator:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10 days of treatment with 3 daily doses of 420 mg (available in an capsule of 210 mg), as recommended by the manufacturer. 6 capsules daily for 10 days: 2 capsules in the morning (30 minutes before breakfast), 2 capsules at noon (30 minutes before lunch), 2 capsules in the evening (30 minutes before dinner)
Dietary Supplement: Atusin CAP
10 days treatment with a 3-day dose of 420 mg placebo capsules (available in an indistinguishable capsule of 210 mg). 6 capsules daily for 10 days: 2 capsules in the morning (30 minutes before breakfast), 2 capsules at noon (30 minutes before lunch), 2 capsules in the evening (30 minutes before dinner)
Dietary Supplement: Placebo
This food supplement contains a distillate of 4 types of purified oils - eucalyptus, sweet orange, lemon and myrtle, rich in 1,8-cineol, limonene, alpha-pinene in the ratio: 66:32:1:1, bromelain and green Brazilian propolis in a gastro-resistant capsule. The product contains excipients: microcrystalline cellulose, silica dioxide, copovidone, magnesium stearate.
The placebo product will be identical in shape, appearance and color to the active product and will have the same composition but without the active ingredients.
Bronchitis severity assessment
The bronchitis severity assessment will be performed using the Bronchitis Severity Scale by the Investigator. The intensity of symptoms - frequency of coughing attacks, sputum discharge, rales on auscultation, chest pain on coughing and dyspnea will be assessed using a 5-point Likert scale: 0=Absent (1-2 times/day), 1=mild (3-5 times/day), 2=moderate (6-10 times/day), 3=severe (11-20 times/day), 4=very severe (\>20 times/day). Clinical cure is defined as ⩾75% reduction in baseline Bronchitis Severity Scale after 10 days.
Time frame: Up to 14+2 days after starting treatment
Reduction in cough severity
The severity of the cough by Visual Analogue Scale (VAS) is a single element measure of the subject's current perception of the severity of the cough. It is rated on a scale of 10 cm (100 mm), where "0" stands for "Absent" and "10" represents "The most severe possible cough". The decrease in cough severity per VAS by ⩾ 20 mm is assumed to be significant in this study.
Time frame: Up to 14+2 days after starting treatment
Reduction of the duration (in days) of moderate to severe cough
Number of continuous days with moderate to severe cough. The severity of cough is assessed by the subject every evening at bedtime on Day 1 through Day 10, using the Visual Analogue Scale (VAS). The duration of moderate to severe cough will be calculated taking into account the number of consecutive days (2, 3,..10) in which the subject noted severity of cough of ≥ 5.
Time frame: up to 14+2 days after start of treatment
Frequency of daytime cough attacks
An attack is defined as a single cough of 3 or more consecutive coughs. Evaluated by: * Investigator at subject enrollment, during screening at Visit 1 (V1) (Day 1), and the data will serve as a baseline, and on V2, V3 and V4 using the Bronchitis Severity Scale. * Subject every evening at bedtime on Day 1 through Day 10, using an Acute Bronchitis Severity Score.
Time frame: Up to 14+2 days after start of treatment
Reduction in the frequency of nocturnal cough
The baseline frequency of cough attacks is evaluated by the Investigator at subject enrollment during screening Visit 1 (V1; CRF record) Day 1, using the Bronchitis Severity Scale and by the subject every evening at bedtime on Day 1 through Day 10, using the Acute Bronchitis Severity Score. The frequency of nighttime cough will be assessed daily from Day 1 (enrollment) to Day 10 and changes in its frequency will be analyzed after 1-10 days from baseline (change in day/night cough frequency after k days of treatment = frequency of day/night cough after k days of treatment - frequency of cough at enrollment (Day 1), where k = 1, 2,...,10).
Time frame: Up to 10 days after the start of treatment
Quality of life (QoL)
Limitation of daily activity is assessed by the Investigator at trial entry and by subject every evening at bedtime on Day 1 through Day 10 using the Acute Bronchitis Severity Score (ABSS).
Time frame: Up to 10 days after start of treatment
Adverse events
Incidence of mild (e.g. self-resolving), moderate (e.g. those requiring medical evaluation) and severe (e.g. those requiring prolonged hospitalization) serious and non-serious adverse events.. Recorded daily by the subjects in ePD and by Investigators in eCRF
Time frame: Up to 14+2 days after starting treatment
Response to treatment
At each visit during/after treatment (V2, V3 and V4), response to treatment is assessed by the Investigator using a verbal rating scale (VRS): 0 = symptoms resolved \[resolved\], 1 = symptoms improved compared to baseline, 2 = symptoms unchanged compared to baseline, 3 = symptoms worsened compared to baseline. Subjects with points 0 or 1 are defined as "responders"; subjects with points 2 or 3 were defined as "non-responders".
Time frame: Up to 14+2 days after starting treatment
Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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